510(k) · Cleared
ClearedUF (II) Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dio Corporation · DZE Implant, Endosseous, Root-Form
Cleared on Mar 30, 2018 as substantially equivalent to K122519 (Dio Corporation, 2013) after a 394-day review. Its family tree reaches back 3 generations to 2004. 4 later devices descend from it.
- Decided
- Mar 30, 2018
- Review
- 394 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K041368 (2004). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK041368 Dentium CO., LTD. ImplantiumDentium Co., Ltd. · 2004 · Recalled
- 2 generations backK060501 Implantium IIDentium Co., Ltd. · 2006
- 1 generation backK122519 Dio UF Hsa Internal Sub-Merged Implant SystemDio Corporation · 2013
- This deviceK170608 UF (II) Implant SystemDio Corporation · 2018
- Descendant · cites it directly · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · cites it directly · 0 of its ownK260006 INOSS SystemInosys, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK202832 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021
- Descendant · 2 generations on · 0 of its ownK192839 DSP Implant SystemD.S.P Industrial Eireli · 2021
Most influential descendants
Showing 4 of 4 · See all- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · cites it directly2descendants
- K260006INOSS SystemInosys, Inc. · 2026 · cites it directly0descendants
- K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021 · 2 generations on0descendants
- K192839DSP Implant SystemD.S.P Industrial Eireli · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K041368 | Dentium CO., LTD. Implantium | Dentium Co., Ltd. | 2004 | 1 |
| −2 | K060501 | Implantium II | Dentium Co., Ltd. | 2006 | — |
| −1 | K122519 | Dio UF Hsa Internal Sub-Merged Implant System | Dio Corporation | 2013 | — |
| 0 (this device) | K170608 | UF (II) Implant System | Dio Corporation | 2018 | — |
| +1 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +1 | K260006 | INOSS System | Inosys, Inc. | 2026 | — |
| +2 | K202832 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2021 | — |
| +2 | K192839 | DSP Implant System | D.S.P Industrial Eireli | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122519 | Dio UF Hsa Internal Sub-Merged Implant SystemSummary page 4…when good primary stability is achieved with appropriate occlusal loading. Predicate devices Primary Predicate Device : DIO UF HSA Internal Sub-merged Implant System(K122519) Reference Device : Implantium II (K060501) UF(II) Narrow Implant System – Fixture, UF(II) Narrow Implant S… | 2013 |
| † | K060501 | Implantium II | 2006 |
| † | K161987 | UF (II) Narrow Implant System - Fixture, UF (II) Narrow Implant System - Suprastructure | 2017 |
| † | K070569 | SM Internal./External Implant System | 2007 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K183024 (Implacil DE Bortoli Material Odontologico Ltda, 2020) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K122519.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The UF(II) Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The UF(II) Implant System(Ø3.8 ~ Ø5.5) can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170608: UF (II) Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170608
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026